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OpenTrials
Completed

NCT Number: NCT03199872

RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rigshospitalet

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients prostatectomised (PT) due to histologically verified adenocarcinoma of the prostate gland who currently are not being treated, or expected within the next 8 months to be treated, with any anti-cancer treatment.
  • ECOG performance status 0 or 1.

Exclusion criteria

  • Patient has been treated with Androgen Deprivation Therapy (ADT), or expected to receive such treatment within the next 8 months from enrolment.
  • Severe medical conditions, such as but not limited to severe asthma/chronic obstructive pulmonary disease (COPD), New York Heart Association (NYHA) grading 3 or above, poorly regulated insulin dependent diabetes, any significant organ damage as judged by the Investigator.

Treatment and study plan

RV001V

Biological

Sc injection

Primary outcomes

  1. Proportions of Participants With Treatment-related Adverse Events

    Time frame: 8 month

    Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary outcomes

  1. Immunological Response

    Time frame: 12 months

    RV001-specific immunological response after treatment from baseline to each treatment and follow-up

Sponsors and collaborators

Lead sponsor

RhoVac APS

Industry

Collaborators

  • Dantrials Aps

Registry information

Official study title

A Phase I/II Study of RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 27, 2017
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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